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Study of Belantamab Mafodotin in Combination With Kd for the Treatment of Relapsed Myeloma Patients, Refractory to Lenalidomide

NCT05060627 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-11

No results posted yet for this study

Summary

This is a phase I-II open-label, multicenter, non-randomized study aiming to evaluate the efficacy and safety of belantamab mafodotin in combination with carfilzomib (Kyprolis®) and dexamethasone (Kd). Since this is the first time that this combination is being evaluated in a clinical trial, a first dose escalation part will be developed following the classic 3+3 design, to establish the maximum tolerated dose (MTD) of the combination. Once the MTD will be defined, a dose expansion phase will be open to recruit up to 60 patients.

Patients will receive treatment with belantamab-mafodotin + Kd, until unacceptable toxicity, disease progression, patient withdrawal, loss to follow-up, end of study, or death.

Conditions

  • Relapsed Multiple Myeloma

Interventions

DRUG

Belantamab mafodotin

In phase 1: * Dose level -1: Belantamab-Mafodotin 1.9 mg/kg day 1, Q8W * Dose level 1,2,3: Belantamab-Mafodotin 2.5 mg/kg day 1, Q8W In phase 2: maximum tolerated dose (MTD) of the combination

DRUG

Carfilzomib

In phase 1: * Dose level -1, 1: Carfilzomib 20/45 mg/m2 days 1, 8, and 15, Q4W. * Dose level 2: Carfilzomib 20/56 mg/m2 on days 1, 8, and 15, Q4W * Dose level 3: Carfilzomib 20/70 mg/m2 on days 1, 8, and 15, Q4W. In phase 2: maximum tolerated dose (MTD) of the combination

DRUG

Dexamethasone

Description: Dexamethasone 40 mg weekly (days 1, 8, 15 and 22) or 20 mg in patients \> 75 years old., Q4W

Sponsors & Collaborators

  • Adknoma Health Research

    collaborator INDUSTRY

  • PETHEMA Foundation

    lead OTHER

Principal Investigators

  • Paula Rodríguez Otero · Clínica Universidad de Navarra

  • María-Victoria Mateos · University of Salamanca

  • Jesús San Miguel Izquierdo · Clínica Universidad de Navarra

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-20
Primary Completion
2024-10-23
Completion
2028-05-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05060627 on ClinicalTrials.gov